Safety Evaluation of the KLOX BioPhotonic System in Stage II and III Pressure Ulcers
NCT02222454 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2016-02-23
Summary
The primary objective of these case series is to evaluate the safety and tolerability of the KLOX BioPhotonic System as adjunctive therapy to Standard Of Care (SOC) in patients with stage II or III pressure ulcers.
Conditions
- Pressure Ulcers Stage II
- Pressure Ulcers Stage III
Interventions
- DEVICE
-
KLOX BioPhotonic System
KLOX BioPhotonic System (Multi-LED Light and KLOX Photo Converter Wound Gel) will be administered until wound closure or for a maximum of 16 weeks, followed by a 8-week follow-up period, in association with Standard Of Care for pressure ulcers.
Sponsors & Collaborators
-
KLOX Technologies Inc.
lead INDUSTRY
Principal Investigators
-
David Keast, Dr · Lawton Research Institute, London, Ontario, Canada
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-11-30
- Primary Completion
- 2015-08-31
Countries
- Canada
Study Locations
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